MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 24"(60CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE

Model Number	8205H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Attempts to obtain the following information has been performed but not received.If the further details are received at a later date a supplemental medwatch will be sent could you please confirm how many needles were involved in the event? could you please confirm if this happen several times in the same procedure or in another procedures? if it occurred in others, were they reported in another complaint? what is the procedure date? what is the event day? to date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.Note: events reported via mw# 2210968-2020-03871, 2210968-2020-03875, 2210968-2020-03876, 2210968-2020-03877, 2210968-2020-03878,2210968-2020-03879,2210968-2020-03880, 2210968-2020-03881, 2210968-2020-03882, 2210968-2020-03883.
Event or Problem Description
It was reported a patient underwent an unknown procedure on an unknown date in 2020 and suture was used.During use, it was observed that the needle popped off of the suture.A new box was opened to complete the procedure.There were no patient consequences reported.
Additional Manufacturer Narrative
(b)(4).Date sent to the fda: 05/19/2020.A manufacturing record evaluation was performed for the finished device lot number plq052, and no non-conformances were identified.Additional h3 investigative summary: one open box with unopened samples of product code 8205, lot plq052 was received for analysis.During the visual inspection of the samples, no defects were found on the packages.The samples were opened, and the swage and attachment area were noted to be as expected.The sutures were dispensed without problems and examined along of the strands and no defects were observed.A functional test was performed and the pull force were above the minimum requirements.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the condition of the samples, no performance pull off suture needle was found, and the tested samples met the finished goods requirements.

• Brand Name: PROLENE SUTURE 24"(60CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10049291
• Report Number: 2210968-2020-03883
• Device Sequence Number: 2826927
• Product Code: GAW
• UDI-Device Identifier: 10705031013292
• UDI-Public: 10705031013292
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K133356
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 8205H
• Device Catalogue Number: 8205H
• Device Lot Number: PLQ052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2020
• Initial Date Received by Manufacturer: 04/30/2020
• Supplement Date Received by Manufacturer: 05/18/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 05/19/2020
• Patient Sequence Number: 1